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FDA 510(k)

TOPEZ TOTAL ANKLE REPLACEMENT

K-Number: K051023 · 2005-11-15

ApplicantTopez Orthopedics, Inc.
Decision Date2005-11-15
Product CodeHSN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TOPEZ TOTAL ANKLE REPLACEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Topez Orthopedics, Inc.. It received FDA 510(k) clearance on 2005-11-15 under 510(k) number K051023. The device is classified under product code HSN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOPEZ TOTAL ANKLE REPLACEMENT?

TOPEZ TOTAL ANKLE REPLACEMENT is a medical device that received FDA 510(k) clearance on 2005-11-15. The listed applicant is Topez Orthopedics, Inc.. The 510(k) number is K051023.

When did TOPEZ TOTAL ANKLE REPLACEMENT receive FDA 510(k) clearance?

TOPEZ TOTAL ANKLE REPLACEMENT received FDA 510(k) clearance on 2005-11-15, under 510(k) number K051023.

Who is the listed applicant for TOPEZ TOTAL ANKLE REPLACEMENT?

The FDA 510(k) record lists Topez Orthopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TOPEZ TOTAL ANKLE REPLACEMENT?

The FDA product code for TOPEZ TOTAL ANKLE REPLACEMENT is HSN.

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Related Devices (Code: HSN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253159Prophecy Incompass Surgical Planning SystemWright Medical Technology, Inc. (Stryker)K252454Kinos Total Ankle SystemRestor3DK250037Incompass Total Ankle SystemWright Medical Technology, Inc. (Stryker)K250641APEX 3D Total Ankle Replacement SystemParagon 28, Inc.K240475Hintermann Series H2 Total Ankle SystemVilex, LLCK241999Prophecy Surgical Planning SystemWright Medical Technology, Inc. (Stryker)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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